Class III · Low risk Terminated
Avicel PH- 102 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Avicel PH- 101 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Ongoing
Atropine Sulfate Ophthalmic Solution
Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Class III · Low risk Terminated
Clobetasol propionate Cream USP
Reason Subpotent Drug: Low assay result observed during long-term stability testing.
Class III · Low risk Terminated
FentaNYL Citrate 2.5mg/50mL
Reason Short Fill: Underfilled units.
Class III · Low risk Terminated
Levofloxacin Tablets
Reason Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class III · Low risk Terminated
Sinuva
Reason Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Class III · Low risk Terminated
Prochlorperazine Maleate Tablets
Reason Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Class III · Low risk Terminated
Timolol Maleate Ophthalmic Solution
Reason Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Class III · Low risk Terminated
Lacosamide Oral Solution
Reason Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Class III · Low risk Terminated
Allergy Relief D
Reason Failed dissolution specifications
Class III · Low risk Terminated
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Reason Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class III · Low risk Terminated
Phenytoin Sodium Injection
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III · Low risk Terminated
Phenytoin Sodium Injection
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Capsules
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Capsules
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Terminated
Susvimo
Reason Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
Class III · Low risk Terminated
Fyarro
Reason Failed Stability Specifications
Class III · Low risk Terminated
NDC 0363-6171-09 Walgreens Sinus Pressure
Reason Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class III · Low risk Ongoing
Tranexamic Acid Injection
Reason Presence of Particulate Matter: Piece of metal found in a vial
Class III · Low risk Terminated
oxyTOCIN 30 Units/500 mL
Reason Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Class III · Low risk Terminated
Clonidine Hydrochloride Tablets
Reason Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Class III · Low risk Terminated
Xolegel
Reason Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
Class III · Low risk Completed
Phytonadione Injectable Emulsion USP
Reason Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Class III · Low risk Terminated
Antibacterial Foaming Wash with Hydria Moisturizing Formula
Reason Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.